MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 09/14/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: won ys, rho mh, chung ec, hong hp, kim sy, park hj, choi yj, lee sy, choi cs, ihn yk.Multiple overlapping stent-assisted coiling of complex aneurysms: a single-center experience.Neurol res.2015 mar;37(3):189-96.Doi: 10.1179/1743132814y.0000000444.Epub 2014 sep 12.Erratum in: neurol res.2015 apr;37(4):375.Yon, yu sam [corrected to won, yu sam].Pmid: 25213599.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source and the following citation was reviewed: won ys, rho mh, chung ec, hong hp, kim sy, park hj, choi yj, lee sy, choi cs, ihn yk.Multiple overlapping stent-assisted coiling of complex aneurysms: a single-center experience.Neurol res.2015 mar;37(3):189-96.Doi: 10.1179/1743132814y.0000000444.Epub 2014 sep 12.Erratum in: neurol res.2015 apr;37(4):375.Yon, yu sam [corrected to won, yu sam].Pmid: 25213599.Objective and methods: the purpose of this study was to evaluate the feasibility and mid-term outcomes of complex aneurysms after multiple overlapping stent assisted coiling (osac).Retrospectively evaluated 26 wide-necked and fusiform atherosclerotic or dissecting aneurysms (captured in table 1) that were treated with multiple osac.Eight aneurysms (30.8%) presented with subarachnoid hemorrhage and one (3.9%) with intracranial hemorrhage.The article reports procedures utilized cerenovus and non cerenovus products within the study group and only identifies which manufacturers stent(s) were utilized in each patient.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Other cerenovus devices that were also used in this study: 6f envoy guiding catheter non-cerenovus devices that were also used in this study: 6f shuttle sheath (cook), closing device (angioseal -st jude medical), perclose (abbott), neuroform stent (boston scientific), solitaire stent (ev3).Coils were utilized but the article does not identify manufacturer of coils.Article also does not identify which manufacturer devices are associated with the adverse events (besides the stent).Adverse event(s) and provided interventions (cross reference of table 1 with narrative descriptions): (b)(6) female with ica unruptured aneurysm location implanted with enterprise stent experienced in-stent thrombosis treated with tirofiban injection with resolution of thrombosis but decreased mental status outcome.(b)(6) female with mca unruptured aneurysm location implanted with enterprise stent experienced in-stent thrombosis treated with tirofiban injection with transient right sided weakness.(b)(6) male with mca unruptured aneurysm location implanted with enterprise stent experienced in-stent thrombosis treated with tirofiban injection with no information on outcome.(b)(6) male with mca unruptured aneurysm location implanted with enterprise stent experienced in-stent thrombosis treated with tirofiban injection with no information on outcome.(b)(6) male with sca unruptured aneurysm location implanted with enterprise stent experienced in-stent thrombosis treated with tirofiban injection with outcome of aphasia with quadriplegia.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle nechatel CH240 0; SZ CH2400
• MDR Report Key: 12599536
• MDR Text Key: 280448335
• Report Number: 1226348-2021-00092
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F ENVOY GUIDING CATHETER; 6F SHUTTLE SHEATH (COOK); CLOSING DEVICE (ANGIOSEAL -ST JUDE MEDICAL); NEUROFORM STENT (BOSTON SCIENTIFIC); PERCLOSE (ABBOTT); SOLITAIRE STENT (EV3)
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR